Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002070
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Phase III Ganciclovir - rGM-CSF for AIDS-Related CMV Retinitis
Sponsor:
Schering-Plough
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Phase III Ganciclovir - rGM-CSF for AIDS-Related CMV Retinitis
Status:
COMPLETED
Status Verified Date:
1991-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether co-administration of sargramostim granulocyte-macrophage colony-stimulating factor GM-CSF improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cellsmm3 To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis to confirm the safety and co-administration of ganciclovir and GM-CSF to assess the changes in the expression of HIV p24 antigen in the serum and number of T4 lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C88-059 | None | None | None |